Implementation of an Evidence-Based PTSD Treatment in Public Sector Settings

描述（由申请人提供）：女性创伤后应激障碍是一种特别有害的慢性疾病，与显著的精神共病、高自杀率、药物滥用、自残和多重创伤（包括反复的性侵犯和家庭暴力）相关。公共部门心理健康服务是受创伤妇女的不成比例的接受者，62%至98%寻求治疗的妇女报告有创伤史，其中高达40%的人被诊断患有创伤后应激障碍并伴有各种合并症。超过40个认知行为治疗PTSD的单点随机试验已经进行。然而，迄今为止，只有两项大样本随机临床试验评估了这种治疗在社区中的有效性，这两项试验都涉及军人。本申请旨在评估基于证据的创伤后应激障碍治疗在四家公共精神卫生诊所合作伙伴关系的背景下的有效性，这些诊所服务于不同的人群。干预包括两个模块，顺序治疗（STAIR/MPE），其中第一个模块强调以现在为重点的情感和人际调节技能训练（STAIR），用于日常生活困难，第二个模块结合了以过去为重点的创伤处理工作，使用改进版本的延长暴露（MPE）。这种认知行为治疗是专门为治疗高风险、多重创伤的慢性PTSD女性而设计的，并已被证明能显著缓解PTSD，并改善情绪管理和人际功能。我们将在日常临床护理的背景下评估STAIR/MPE与常规治疗（TAU）的有效性。该研究是一项随机、对照、重复测量的意向治疗设计，以评估治疗后、3个月和6个月随访时STAIR/MPE与TAU的比较。四个地点（安大略省西部、波士顿、纽约和亚特兰大），每个地点都位于一个大型的公共部门心理健康网络中，将招募88名寻求治疗的与人际暴力有关的创伤后应激障碍妇女，总共352名研究参与者。主要结果是PTSD症状的严重程度。次要结果为负性情绪调节、自我效能、人际关系问题和一般精神障碍水平（GAF评分）。探索性目标包括检查治疗实施变化与治疗结果之间的关系，以及患者特征和其他可能影响实施的环境变量（治疗师和组织）的影响。我们还将引入基于网络的技术作为一种资源，旨在加强临床网络，并在试验结束后保持研究材料的使用。

DESCRIPTION (provided by applicant): PTSD among women is a particularly pernicious and chronic disorder associated with significant psychiatric comorbidity, high rates of suicidality, substance abuse, self-injury and multiple traumatization including repeated sexual assault and domestic violence. Public-sector mental health services are the disproportionate recipient of traumatized women with between 62% to 98% of treatment seeking women reporting a history of trauma and of those, up to 40% carry a diagnosis of PTSD with various comorbidities. Over 40 single-site randomized trials of cognitive-behavioral therapy for PTSD have been conducted. However, to date, there are only two large-sample randomized clinical trials which have evaluated the effectiveness of such treatments in the community and both of them concerned military populations. This application proposes to evaluate the effectiveness of an evidence-based PTSD treatment in the context of a collaborative partnership of four public mental health clinics serving diverse populations. The intervention is a two module, sequential treatment (STAIR/MPE) in which the first module emphasizes present-focused skills training in affective an interpersonal regulation (STAIR) for day-to-day life difficulties and the second module incorporates past-focused work on the processing of the trauma, using a modified version of prolonged exposure (MPE). This cognitive behavioral treatment was specifically designed to treat high risk, multiply traumatized women with chronic PTSD and has been demonstrated to provide significant and clinically substantial relief from PTSD as well as improvement in emotion management and interpersonal functioning. We will assess the effectiveness of STAIR/MPE compared to Treatment as Usual (TAU) in the context of every day clinical care. The study is a randomized, controlled repeated measures intent-to-treat design to assess STAIR/MPE as compared to TAU at post-treatment and three and six-month follow-up. Four sites (Western Ontario, Boston, New York and Atlanta), each situated within a large public sector mental health network, will enroll 88 treatment-seeking women with PTSD related to interpersonal violence yielding a total of 352 study participants. The primary outcome will be PTSD symptom severity. Secondary outcomes will be negative mood regulation self-efficacy, interpersonal problems and general level of psychiatric impairment (GAF scores). Exploratory aims include the examination of the relationship between variations in treatment implementation and treatment outcome as well as the influence of patient characteristics and other contextual (therapist and organization) variables likely to impact implementation. We will also introduce web-based technology as a resource intended to strengthen clinical networks and maintain use of study materials after the trial has ended. PUBLIC HEALTH RELEVANCE: The primary aim of the current proposal is to evaluate the effectiveness of a cognitive-behavioral treatment in resolving PTSD related to interpersonal violence among women seeking treatment in public sector mental health services. The therapy, a sequential modular treatment comprised of skills training followed by exposure (STAIR/MPE) will be compared to Treatment as Usual (TAU) in a multisite randomized controlled trial of four public mental health outpatient clinics.